A STUDY TO DEMONSTRATE THE EQUIVALENCE IN EFFICACY AND SAFETY OF ONCE-DAILY NISOLDIPINE-CC AND AMLODIPINE IN THE TREATMENT OF MILD-TO-MODERATE HYPERTENSION

Nisoldipine CC and amlodipine are both once-daily calcium channel bloc kers. Amlodipine has proven long action and efficacy in the treatment of mild to moderate hypertension. This study tests the equivalence in efficacy between nisoldipine CC and amlodipine in patients with mild t o moderate essential hypertension (diastolic blood pressure (DBP) 95-1 14 mmHg) over a range of doses (nisoldipine CC, 10, 20, 40 mg od; amlo dipine 5, 10 mg ed). Within the multicentre, randomized, double-blind, double-dummy, dose-titration study, 214 patients were randomized to r eceive either nisoldipine CC (10 mg od) or amlodipine (5 mg ed). Treat ment was titrated at two-weekly intervals as necessary. The primary ef ficacy endpoint was reduction in sitting trough DBP; secondary efficac y endpoints were reductions in systolic blood pressure (SBP) and heart rate. Equivalence between nisoldipine CC and amlodipine was shown for the primary efficacy endpoint. Sitting DBP was reduced by 14.3+/-7.6 mmHg and 13.6+/-6.8 mmHg for nisoldipine CC and amlodipine, respective ly. Response rates at the end of the study were 71% for nisoldipine CC and 75% for amlodipine. Reductions in the secondary efficacy endpoint s were also similar for each drug. The numbers of total and drug-relat ed adverse events were similar for both drugs, and were typical of tho se associated with calcium channel blockers. There were no dose-relate d adverse events for either drug. Nisoldipine CC provides equivalent r eduction in DBP to amlodipine throughout the dose range. Furthermore, the three doses of nisoldipine CC tested in this study demonstrate the potential for enhanced flexibility in the control of mild to moderate hypertension.